Crown Pharmacovigilance Limited

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http://www.crownpharmacovigilance.co.uk/index.html
Crown Pharmacovigilance Limited
Headquarters 51 - 55 Fowler Road

Hainault Essex IG6 3XE,London,UK

Crown Pharmacovigilance Limited (CPL) is a specialist Drug Safety Risk Management consultancy managed from a London office on behalf of associate consultants. [1]

SERVICES

GLOBAL PHARMACOVIGILANCE & DRUG SAFETY RISK MANAGEMENT:

  • Medical assessment of individual case safety reports / raise medically relevant follow-up questions / add medically relevant comment to aid case interpretation / check coding or advise on MedDRA coding
  • Cumulative assessment of adverse event data
  • Signal detection/issue work-ups / drug safety reports of analyses and investigations of specific issues
  • PSUR services
  • Pharmacovigilance & Risk Management Plans
  • Training
  • Pharmacovigilance Audits
  • Pharmacovigilance & Risk Management SOPs
  • Pharmacoepidemiology support
  1. Study designs
  2. Database studies
  3. Project management
  • Issue & Crisis Management

ONE-STOP SHOP FOR START-UP & SMALL COMPANIES:

  • Take care of all pharmacovigilance, devices vigilance and medical affairs
  • EU pharmacovigilance responsible person representation
  • Scientific qualified person representation
  • Contact point for all medical information enquiries and responses
  • Contact point for adverse event reporting, processing and regulatory reporting
  • Medical review and signatory for medical information, scientific and promotional materials

CLINICAL TRIALS SUPPORT SERVICE:

  • Safety input in design of clinical studies
  • Medical review of serious adverse events
  • Narrative writing
  • Writing clinical study reports

TRAINING SERVICES:

  • One to one training
  • Small group training
  • Introductory pharmacovigilance for non-scientists
  • Overview drug safety risk management for senior management
  • In-house training
  • Risk management training
  • SOP training

RECRUITMENT SERVICES: Conduct tailored job search in pharmacovigilance, drug safety or risk management. Associates have the extensive network of contacts in CROs, small, medium and big pharmaceutical and biotech companies.Connecting engaging contacts with good companies. If the move from another function or discipline to drug safety, can provide practical training.

INSPECTION READINESS SERVICES:

  • Inspection readiness training
  • Preparation of summary of pharmacovigilance systems
  • Internal audits
  • Mock interviews
  • Qualified person for pharmacovigilance representation

[2]

Reference

  1. http://www.crownvigilance.com/about-us/
  2. http://www.crownvigilance.com/services/

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